Monday, April 03, 2017

Federal government struggles to hold drug makers accountable for their role in opioid epidemic

Post graphic: Opioid overdoes on the rise
As the opioid epidemic continues to plague the U.S., especially Appalachia and other rural areas, the federal government is struggling to hold drug manufacturers responsible for damage done by their products, Lenny Bernstein and Scott Higham report for The Washington Post.

For example, the Drug Enforcement Administration spent years investigating Mallinckrodt Pharmaceuticals, one of the largest makers of the highly addictive painkiller oxycodone, only to have the company reach a deal in which it "would agree to pay a $35 million fine and admit no wrongdoing," reports the Post. The investigation centered in Florida, where the company failed to report suspicious orders of 500 million of its pills between 2008 and 2012—66 percent of all oxycodone sold in the state. During this time, before it cracked down on "pill mills," Florida was the major source of painkillers for Appalachia.

The company first came under suspicion in 2009 when "members of a Tennessee drug task force in a sting operation seized several 100-tablet bottles of ­Mallinckrodt-made oxycodone," reports the Post. "Task force agents alerted Mallinckrodt. The company’s lot numbers were printed on the labels, allowing for easy tracking of the pills. Under federal law and DEA policy, pharmaceutical companies such as Mallinckrodt are required to 'know their customers' and monitor the pattern, frequency and amounts of drug orders. When suspicious orders occur, companies must immediately notify the agency or risk losing their DEA licenses to sell or manufacture controlled substances, as well as face civil and criminal penalties."

"According to the documents and sources familiar with the settlement talks, Mallinckrodt was willing to acknowledge its responsibility to report suspiciously large orders placed by its customers, a network of wholesale distributors," reports the Post. "But the company said that it should not be held responsible for what happens to its drugs once the distributors send them to their customers, such as doctors and pharmacies. Mallinckrodt contended that the DEA has never required manufacturers to know their customers’ customers and that the agency provided the company with conflicting advice about its responsibilities under the law."

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